ICER Weekly View: February 8, 2019

From the desk of David Whitrap

Good morning, everyone. Below, I’ll touch on what Tuesday’s State of the Union address might mean for the health care industry. But before we get there, I’d first like to state my appreciation for members of both political parties breaking into an impromptu chorus of “Happy Birthday” for Judah Samet, who survived both the Holocaust and October’s mass shooting at the Tree of Life Synagogue. In an era of choreographed partisanship, that was a genuinely unifying and moving moment.

Now let’s take a look at:

  • ICER in the News: Continued commentary about our forthcoming assessment of Unsupported Price Increases.
  • Pharmaceutical News: What the State of the Union means for pharmaceutical research, what happens if rebates go away, the first TV ad to include a drug’s list price, the potential benefits of an infamous party drug, and vice versa, a new pharmaceutical that inadvertently may have led people to seek street drugs instead. Oh, and there’s also the story of a treatment that went from $0 to $375,000 overnight.

ICER in the News

Our new initiative to assess the new clinical evidence that may (or may not) support the most significant increases in drug prices continues to drive discussion among the pharmaceutical trade press. Leela Barham, writing for Pharmaceutical Executive, characterized the potential impact of our annual Unsupported Price Increase (UPI) reports:

“Planning a UPI report is also another way that ICER is marking itself out from other [health technology assessment] agencies… It’s going even further and adding its analysis into a hot topic for policy debate and lawmaking. That illustrates an ambitious agenda.”

Unsupported Price Increases: A New Focus for ICER (Pharmaceutical Executive)

The list of shame no biopharma wants to join

An upcoming Icer report will put the spotlight on unjustified price increases even as signs of moderation emerge.

Pharmaceutical News

Perhaps second only to immigration, health care was a key topic of Tuesday’s State of the Union address. President Trump vowed to lower drug prices, eradicate H.I.V. in the country by 2030, and invest $500 million over ten years into researching new treatments for childhood cancer. Kaiser Health News, the New York Times, and Politico took a look at the feasibility and reaction to each of these proposals (respectively), while STAT News fact-checked the assertion that drug prices are going down.

Trump Highlights Health Agenda With Vow To Lower ‘Unfair’ Drug Prices

It was not the centerpiece, but health was a persistent theme in President Donald Trump’s State of the Union address at the Capitol on Tuesday night. Although the administration has focused more on issues of trade, taxes and immigration, the president laid out a series of health-related goals, including some that even Democrats indicated could be areas of bipartisan negotiation or compromise.

Trump Plan to Stop Spread of H.I.V. Will Target ‘Hot Spot’ Areas

Mr. Azar said that new infections were “highly concentrated among men who have sex with men; minorities, especially African-Americans and American Indians and Alaska Natives; and those who live in the Southern United States.” The South accounted for 52 percent of new H.I.V. diagnoses in 2017, according to the Centers for Disease Control.

Pelosi rips Trump’s childhood cancer research boost as inadequate

House Speaker Nancy Pelosi on Wednesday trashed President Donald Trump’s plan to boost funding for childhood cancer research by $500 million over a decade, deriding his State of the Union proposal as severely lacking. “$500 million over 10 years – are you kidding me?”

Trump claims drug prices have fallen. But he’s cherry-picking that data

Trump asserted that his efforts to bring down drug prices had led to the largest drop in those figures in nearly half a century. That’s not quite right.

The State of the Union came only a couple days after the Administration proposed a new rule to limit pharmaceutical manufacturers’ ability to pay rebates to Medicare plans. STAT News reviewed the potential impact of the proposal on the pharmaceutical and supply chain industries, the Associated Press reported on HHS Secretary Azar’s request to Congress to expand the proposal to private insurance plans, and the Wall Street Journal described how drugmakers have shifted from blaming their price hikes on their own R&D to now just pointing a finger at the supply chain.

Will Trump’s new drug pricing idea end PBMs? And other key questions

W ASHINGTON – The Trump administration’s newest drug pricing idea suggests change on a massive scale: it pitches a wholesale transformation of the way millions of Americans pay for drugs, one that could have a ripple effect into nearly every corner of the country’s health care system.

Trump health chief asks Congress to pass drug discount plan

WASHINGTON (AP) – The Trump administration’s top health official asked Congress on Friday to pass its new prescription drug discount plan and provide it to all patients, not just those covered by government programs like Medicare. The plan would take now-hidden rebates among industry players like drug companies and insurers and channel them directly to consumers when they go to pay for their medications.

Flip the Script: Drugmakers Blame Middlemen for Price Increases

Under pressure over rising drug prices, pharmaceutical companies are pushing a new defense: They’re not raising prices to make money or to cover research costs, but rather to pay a cut to middlemen in the supply chain.

Following up on an earlier Administration proposal, Johnson & Johnson’s Xarelto will be the first drug to have its list price included in TV ads.

Johnson & Johnson will list drug prices in TV commercials

TRENTON, N.J. (AP) – Johnson & Johnson said Thursday it will start giving the list price of its prescription drugs in television ads. The company would be the first drugmaker to take that step. The health care giant will begin with its popular blood thinner, Xarelto, said Scott White, head of J&J’s North American pharmaceutical marketing.

For Bloomberg Businessweek, Cynthia Koons and Bob Langreth wrote a terrific feature about the scientific research and patient experiences that revealed what is now known about the potential effect of a decades-old “club drug” on depression. (This is a very relevant read for anyone who’s following ICER’s ongoing review of treatment-resistant depression.)

Ketamine Could Be the Key to Reversing America’s Rising Suicide Rate
(Bloomberg Businessweek)

As it turns out, the latest reliance on “abuse-deterrent” formulations of opioids inadvertently may have led to increased heroin use, which inadvertently may have led to an uptick in hepatitis C infections. As you may recall, our 2017 assessment of these therapies suggested the possibility of this unintended consequence.

Study: ‘Abuse-deterrent’ OxyContin switch helped drive a hepatitis C spike

W hen Purdue Pharma reformulated its signature pain drug OxyContin in 2010, its aim was to make the pill “abuse-deterrent.” But the change may have had an unanticipated and disastrous public health impact, according to a new study: accelerating a nationwide spike in hepatitis C infections.

And how does a drug that was once free for patients now cost $375,000 per year? Inquiring U.S. Senators want to know.

Sanders asks why once-free drug now costs $375,000 a year

Sen. Bernie Sanders Bernard (Bernie) Sanders Father says he traveled to Canada for son’s medicine that would cost K in US Bernie Sanders, ex-Goldman Sachs boss spar over stock buybacks Analyst says most Americans don’t take issue with higher taxes on the wealthy MORE (I-Vt.)

This week, the FDA warned that patients who had received a certain heart pump were dying at much higher rates in the real world than what was seen in clinical trials. Noting that the real-world patients were in worse health when beginning use of the heart pump, the FDA and the manufacturer created a checklist to help physicians determine which patients may be best suited for the device.

More patients getting an Impella heart device are dying

Details: In 2017, the FDA approved the Impella RP device, which helps pump blood in the right side of the heart and is made by Abiomed. Small studies showed 73% of patients who got the pump were still alive within a month. However: The combined sample size was 60 patients, and trials were not randomized.

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